Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF POSACONAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Gazala Patel*, Rupali Khairate, Ganesh Gajeli and Shivprasad Patil

ABSTRACT

A new, simple, sensitive, accurate and precise UV Visible Spectrophotometric method was developed and validated for the determination of Posaconazole in bulk and pharmaceutical dosage form. The UV spectrum of Posaconazole in acetonitrile showed the maximum absorbance (max) at 263 nm. The method was proved linear in the range of 5-25 g/ml and exhibited good correlation coefficient (R2 = 0.9991). The % RSD for intraday and inter-day precision was found to be 0.885944 and 1.030571 respectively. The LOD and LOQ of Posaconazole was found to be 0.921 and 2.79 respectively. The developed method was validated for linearity, precision, accuracy and robustness, as per ICH guidelines. The obtained results proved that the method can be recommended for the routine analysis of Posaconazole in bulk as well as pharmaceutical dosage form.

Keywords: Posaconazole, Spectrophotometric method, Method Development and Validation, Acetonitrile.